KR102260740B1 - implant delivery device - Google Patents

Abstract

The implant delivery device 100 includes a casing 110; and an inner tube drive member 150 , an outer tube drive member 160 , an inner tube 120 , an intermediate tube 130 , an outer tube 140 , and an air exhaust lock, each of which is at least partially housed in the casing. assembly 170 . The three tubes are sequentially arranged with each other, and the first, second, and third spaces are formed between the passing tubes. The inner tube driving member 150 has a front end sealed and fixed to the front end of the inner tube 120 , the outer tube driving member 160 is sealed and fixed to the front end of the outer tube 140 , and the intermediate tube A reference numeral 130 has a front end sealed and fixed to the inner tube driving member 150 , and the intermediate tube extends through the outer tube driving member 160 and is sealingly connected to the outer tube driving member 160 , The air exhaust lock assembly 170 is removably connected to the inner tube driving member 150 . The inner tube driving member 150 and the air exhaust lock assembly 170 have a first air exhaust channel and a second air exhaust channel A and B, respectively. When the air exhaust lock assembly 170 is connected to the inner tube driving member 150, the second air exhaust channel B is connected to the second space and the third space through the first air exhaust channel A and the first space. connected with space. The inner tube driving member 150 is connected to the casing 110 by an air exhaust lock assembly 170 . When the air exhaust lock assembly 170 is separated from the inner tube driving member 150 , the inner tube driving member 150 remains slidably connected with the casing 110 .

Description

implant delivery device

FIELD OF THE INVENTION The present invention relates to the field of medical device technology, and more particularly, to implant delivery devices.

Heart valve disease is the most frequently diagnosed heart disease in China, and it has been found that most heart valves are damaged by rheumatic fever. In recent years, with the increasing aging population, the incidence of valvular degeneration (including calcification, mucous degeneration, etc.) and valve damage due to metabolic disorders has increased. Conventional heart valve replacement surgery is an open-hear surgery performed under general anesthesia. During surgery, an incision is made along the patient's sternum (so-called "steronotomy"), and then the heart At rest, blood flow is guided through a “cardiopulmonary” bypass machine (also called an “extracorporeal circulation machine”). Therefore, this conventional open heart surgery method has a high risk and causes serious trauma to the patient as well as temporary disturbances that may occur due to embolism and other problems due to the use of a cardiopulmonary machine. Full recovery from trauma usually takes several months. In certain population groups, especially the elderly, trauma can be difficult to bear, and recovery takes longer, sometimes even impossible. Therefore, it is clear that minimally invasive interventional therapy is more promising for patients with heart valve disease.

Minimally invasive surgery does not require sternotomy, minimizes trauma, and has various advantages such as quick recovery of the patient, and has been used intensively in recent years. In particular, considering the practice of minimally invasive surgery over the past decade, it can be seen that minimally invasive surgery can cope with all diseases that can be cured by traditional medical and surgical procedures, as well as some diseases that cannot be treated with traditional approaches. . Since minimally invasive surgery is widely used in clinical practice, more in-depth studies in this field are desirable.

Minimally invasive surgery for heart valve replacement involves implanting an artificial heart valve into the patient's body using a delivery device. However, since the operation of the existing delivery device for the artificial heart valve is complicated and requires a high level of skill from the attending physician, operation problems frequently occur. For example, after an artificial heart valve is delivered and placed at a target location, it is common to cause secondary damage to the patient in the process of retrieving the existing delivery device from the patient's body. In addition, the conventional delivery device is designed to have a hose connected to the external device in the space between the outer tube and the inner tube, so that the fluid flows through the space by injecting a fluid into the hose to discharge air from the system. However, this process may interfere with the invasive surgery. However, in packaging and transporting the delivery device, in addition to the delivery device, a hose must also be secured. When fastening, there is a high probability that the hose will be crushed or bent. In addition, since there is no fixed rail along which the hose can move in the lumen of the handle, the movement of the outer tube or inner tube bends the hose when moving the delivery device forward or backward during surgery, which may make it difficult to exhaust air.

EP 3530236 B1

It is an object of the present invention to provide an implant delivery device for solving one or more of the problems of the prior art described above.

To this end, the present invention provides an implant delivery device, the implant delivery device comprising: a casing; and an inner tube drive member, an outer tube drive member, an inner tube, an intermediate tube, an outer tube, and an air exhaust lock assembly, each of which is received at least partially in the casing. The inner tube, the intermediate tube and the outer tube are sequentially arranged from the inside to the outside. The inner tube and the intermediate tube mutually form a first space, the intermediate tube and the outer tube form a second space with each other, and the inner tube and the outer tube form a third space with each other.

The inner tube driving member has a front end that is sealingly fixed to the front end of the inner tube, and the outer tube driving member is sealed and fixed to the front end of the outer tube. The intermediate tube has a front end sealingly fixed to the inner tube driving member, the intermediate tube extending through the outer tube driving member and sealingly connected to the outer tube driving member. The air exhaust lock assembly is removably connected to the inner tube drive member.

The inner tube drive member has a first air exhaust channel and the air exhaust lock assembly has a second air exhaust channel. The second air exhaust channel protrudes from the casing at a first end and passes through the first air exhaust channel and the first space at a second end when the air exhaust lock assembly is connected to the inner tube drive member. It communicates with the second space and the third space. The inner tube drive member is axially lockable with respect to the casing via the air exhaust lock assembly, and when the air exhaust lock assembly is disengaged from the inner tube drive member, the inner tube drive member moves along the casing. It can slide in the axial direction.

Preferably, the air exhaust lock assembly may include a locking member removably connected to the inner tube drive member and having a lumen extending therethrough to define the second air exhaust channel.

Preferably, the locking member includes a stopper part detachably connectable to the inner tube driving member and a control part for driving the stopper part to move, wherein the control part has a first end located outside the casing, a first lumen extending through a control portion, the stopper portion having a second lumen extending through the stopper portion, the first lumen and the second lumen being in communication with each other to form the second air exhaust channel can

Preferably, the implant delivery device further includes a guide member provided in the casing, wherein the guide member has a guide channel extending therethrough, and the stopper portion is the inner tube along the extension direction of the guide channel. movable with respect to the drive member.

Preferably, the inner tube drive member has a third lumen and a fourth lumen, the third lumen extending axially through the inner tube drive member, the third lumen coincident with the front end of the intermediate tube and a front end coincident with the front end of the inner tube, and the fourth lumen constitutes the first air exhaust channel and may communicate with the first space.

Preferably, the outer tube drive member has a fifth lumen extending axially therethrough, wherein a front end of the outer tube is located in the fifth lumen, and the intermediate tube is disposed from the inner tube drive member to the fifth lumen. It can be extended through the lumen.

Preferably, the air exhaust lock assembly includes a locking member removably connected to the inner tube driving member and a fluid member fixedly connected to the locking member, the locking member having a portion located outside the casing, a sixth lumen in communication with the first air leak channel, the fluid member having a seventh lumen extending therethrough, the sixth lumen and the seventh lumen forming the second air leak channel can be interconnected for

Preferably, the locking member includes a stopper part detachably connectable to the inner tube driving member and a control part for driving the stopper part to move, the control part having a first end located outside the casing, The stopper part may include the sixth lumen.

Preferably, the stopper portion includes a stopper body detachably connected to the inner tube driving member and an elastic structure connected to the stopper body, wherein the stopper portion is connected to the inner tube driving member through the elastic structure, and the When the elastic structure is stressed, the stopper portion may be separated from the inner tube driving member.

Preferably, the air exhaust lock assembly may include a flow control member for controlling the flow direction of the air exhaust medium. The flow control member may be disposed in the second air outlet channel.

Preferably, the flow control member may have a one way check valve or a control lock valve.

Preferably, the intermediate pipe has an air exhaust opening at a rear end through which the first space communicates with the second space, wherein when the air exhaust lock assembly is connected to the inner tube driving member, the second air exhaust channel The second end may be brought into communication with the second volume and the third volume through the first air outlet channel, the first volume, and the air outlet opening.

Preferably, the intermediate tube may have a plurality of air outlet openings uniformly distributed around the circumference of the intermediate tube.

Preferably, the rear end of the intermediate tube is fixed to the inner tube, but may not be sealed.

Preferably, the implant delivery device further includes a movement control member and a movement guide track, wherein the movement guide track is disposed on the casing, the movement control member is disposed on the movement guide track and drives the outer tube can be connected to the member.

In summary, the inner tube of the implant delivery device of the present invention may be connected to or movable relative to the casing by engagement or disengagement between the inner tube drive member and the air exhaust lock assembly, as required. Thereby, when the delivery device is withdrawn after implant delivery, the outer tube remains stationary, and the inner tube driving member is air driven so that the inner tube moves within the casing and approaches and abuts the outer tube to close the outer tube. Released from the ejection lock assembly, the delivery device is then withdrawn from the patient's body. Specifically, the sheath needs to be relatively rigid because the sheath disposed at the rear end of the outer tube must constrain the implant to the crimping configuration. For this reason, in the prior art, if the inner tube and the outer tube are driven to be adjacent to each other for closure after implant placement, secondary damage is caused to the patient's body by the sheath. Conversely, according to the present invention, the inner tube is made of a material having a smaller size, greater bendability and flexibility, and the rear end is adjacent to the rear end of the outer tube through displacement to close the outer tube. Due to this, it is possible to lower the risk of causing secondary damage to the patient's body during recovery. Additionally, in the implant delivery device of the present invention, the second air exhaust channel disposed in the air exhaust lock assembly is intermediate through the first air exhaust channel in the inner tube drive member and the first space between the intermediate tube and the inner tube. It communicates with the second space between the tube and the outer tube and the third space between the outer tube and the inner tube, so that air can be discharged from between the inner tube and the outer tube. This design solves the problem of using an air exhaust lock assembly instead of an air exhaust hose, where the use of the air exhaust hose deforms or blocks the air exhaust path, making it impossible to exhaust the air from the system. In addition, this air exhaust and lock integrated design integrates the air exhaust and lock function, thereby reducing the number of components required and simplifying the operation process. As a result, the delivery device can be used more conveniently with increased performance rigidity.

1 is a schematic diagram illustrating an implant delivery device according to a first embodiment of the present invention without a casing;
2 is a schematic diagram illustrating an air-evacuation locking assembly connected to an inner tube drive member in an implant delivery device according to a first embodiment of the present invention;
FIG. 3 is an enlarged view illustrating part M of the implant delivery device of FIG. 2 ;
Fig. 4 is a partial schematic view showing the air exhaust lock assembly separated from the inner tube driving member in the implant delivery device according to the first embodiment of the present invention.
5 is a schematic diagram showing an intermediate tube according to a first embodiment of the present invention;
FIG. 6 is a cross-sectional view showing the middle tube cut along the line HH of FIG. 5 .
7 is a schematic diagram illustrating a one-way check valve according to an example of the first embodiment of the present invention.
8 is a schematic diagram showing another one-way check valve according to a preferred example of the first embodiment of the present invention.
9 is a schematic diagram illustrating an implant delivery device according to a second embodiment of the present invention without a casing.
10 is a schematic diagram illustrating an air exhaust lock assembly connected to an inner tube drive member in an implant delivery device according to a second embodiment of the present invention.
11 is a partial schematic view showing the air exhaust lock assembly separated from the inner tube driving member in the implant delivery device according to the second embodiment of the present invention.

The implant delivery device according to the present invention will be described in detail below with reference to FIGS. 1 to 11 so that the objects, advantages and features of the present invention are clear. It should be noted that the drawings have been drawn out of scale with considerable simplification, and this is solely for the purpose of facilitating easy and clear description of the embodiments.

As used in the text and appended claims, the term “or” is intended to mean “and/or” unless the context clearly dictates otherwise. The term “distal end” refers to one end that is remote from the person operating the device, and the term “proximal end” refers to the end close to the person operating the device.

Throughout the drawings, like reference numbers indicate like elements. The implant delivery device of the present invention can be used to deliver an implant (eg, an artificial heart valve) to a target site in a human body and place the implant at the target site.

<Example 1>

1 to 4, FIG. 1 is a schematic diagram illustrating an implant delivery device according to a first embodiment of the present invention, and FIG. 2 is an interior view of the implant delivery device according to the first embodiment of the present invention. A schematic diagram showing an air exhaust lock assembly connected to a tubular drive member, FIG. 3 is an enlarged view showing part M of the implant delivery device of FIG. 2 , and FIG. 4 is an implant delivery according to a first embodiment of the present invention. A partial schematic view showing the air exhaust lock assembly separated from the inner tube drive member in the device. For a clearer understanding of the internal structure of the implant delivery device, the casing 110 is not shown in FIG. 1 .

The implant delivery device 100 according to this embodiment has a casing 110 and an inner tube 120, an intermediate tube 130, an outer tube 140, and an inner tube that are partially accommodated in the casing 110, respectively. member 150 , an outer tube driving member 160 , and an air exhaust lock assembly 170 . The inner tube 120 , the intermediate tube 130 , and the outer tube 140 are sequentially arranged from the inside to the outside. The inner tube 120 and the intermediate tube 130 form a first space therebetween. The middle tube 130 and the outer tube 140 form a second space therebetween, and the inner tube 120 and the outer tube 140 form a third space therebetween.

The inner tube driving member 150 has a rear end sealed and fixed to the rear end of the inner tube 120 , and may drive the inner tube 120 to move in the axial direction along the casing 110 . The outer tube driving member 160 may be sealed and fixed to the rear end of the outer tube 140 , and may drive the outer tube 140 to move in the axial direction along the casing 110 . The intermediate tube 130 has a front end sealed and fixed to the inner tube driving member 150 . Additionally, the intermediate tube 130 extends through the outer tube driving member 160 and is sealingly connected to the outer tube driving member 160 . The air exhaust lock assembly 170 is removably connected to the inner tube drive member 150 .

The inner tube driving member 150 has a first air exhaust channel A (preferably extending in a radial direction), and the air exhaust lock assembly 170 has one end casing for receiving the external air exhaust medium. It has a second air outlet channel (B) located on the outside of the (110). When the air exhaust lock assembly 170 is connected to the inner tube driving member 150, the other end of the second air exhaust channel B is connected to the second space and the third space through the first air exhaust channel A and the first space. In communication with the space, the external air discharge medium may be introduced into the second space and the third space to discharge air therefrom. Furthermore, when the air exhaust lock assembly 170 is connected to the inner tube driving member 150 , the inner tube drive member 150 is connected to the casing 110 through the air exhaust lock assembly 170 , and the inner tube 120 . ) and enables an indirect connection between the casing 110 . On the other hand, when the air discharge lock assembly 170 is separated from the inner tube driving member 150 , the inner tube driving member 150 is slidably connected to the casing 110 . That is, the inner tube driving member 150 may move in the axial direction along the casing 110 in the casing 110 . It will be appreciated that the air exhaust lock assembly 170 can be connected to an external device that supplies the air exhaust medium so that the air exhaust medium enters the second air exhaust channel B.

Preferably, the intermediate tube 130 may form an air exhaust opening 131 that allows the first space and the second space to communicate with each other (as more clearly shown in FIGS. 5 and 6 , the air exhaust opening ( 131 may extend through the wall of the intermediate tube 130). When the air exhaust lock assembly 170 is connected to the inner tube driving member 150, the other end of the second air exhaust channel (B) connects the first air exhaust channel (A), the first space, and the air exhaust opening (131). It will be in communication with the second space and the third space through the

The implant delivery device 100 of the first embodiment will be described in more detail below with reference to FIGS. 1 to 8 .

In this embodiment, the air discharge locking assembly 170 may include a locking member 171 removably connected to the inner tube driving member 150 . A portion of the locking member 171 may be located outside the casing 110 so that a user can easily operate the locking member 171 . In particular, to form the second air outlet channel B, the locking member 171 may form a lumen extending therethrough.

Also, the locking member 171 may include a control unit 1711 and a stopper unit 1712 . The control unit 1711 is located outside the casing 110 and one end is connected to an external device, and drives the stopper unit 1712 so that the stopper unit 1712 moves with respect to the inner tube driving member 150 , and the other end is a stopper. may be connected to unit 1712 . The stopper unit 1712 may be accommodated in the casing 110 and coupled to the inner tube driving member 150 under the driving of the control unit 1711 .

Also, each of the control unit 1711 and the stopper unit 1712 may be hollow (ie, each of them may form a through lumen). Hereinafter, the lumen of the control unit 1711 will be referred to as a “first lumen” and the lumen of the stopper unit 1712 will be referred to as a “second lumen”. In one embodiment of the present invention, the first lumen and the second lumen may directly communicate with each other to constitute the second air exhaust channel (B). Preferably, the control unit 1711 may be integrated with the stopper unit 1712 .

In the present embodiment, the locking member 171 can lock the inner tube driving member 150 as well as deliver the air exhaust medium, so that the inner tube driving member 150 is connected with the casing 110 as a result. Of course, when the locking member 171 is separated from the inner tube driving member 150 , the inner tube driving member 150 may move with respect to the casing 110 . Specifically, the locking member 171 is detachably connected to the inner tube driving member 150 , and when the locking member 171 locks the inner tube driving member 150 , the locking member 171 is connected to the casing 110 . It is fixed relative to the casing 1 along the axial direction so that the inner tube drive member 150 cannot move axially along the casing 110 . When the inner tube driving member 150 is unlocked by the locking member 171 , the locking member 171 is separated from the inner tube driving member 150 , and the inner tube driving member 150 is attached to the casing 110 . relative to and along the casing 110 .

The inner tube driving member 150 may form a receptacle (not shown) complementary to the stopper portion 1712 . The receptacle may receive at least a portion of the stopper portion 1712 to limit the axial displacement of the inner tube driving member 150 . Furthermore, the first air exhaust channel A may be formed by the receptacle. That is, when the stopper portion 1712 is accommodated in the receptacle, the second air exhaust channel B will be connected to the first air exhaust channel A. As shown in FIG. Alternatively, the stopper portion 1712 may be implemented as a receptacle, so that the inner tube driving member 150 has a protrusion complementary to the stopper portion 1712 . In this case, the second air discharge channel (B) and the first air discharge channel (A) may be similarly connected by coupling the stopper unit 1712 and the inner tube driving member 150 .

Preferably, in this embodiment, one end of the stopper portion 1712 facing the receptacle may take the form of a tapered protrusion capable of engaging with the receptacle of the inner tube driving member 150. . This provides a simple structure that enables smooth coupling between the stopper portion 1712 and the receptacle.

In one embodiment, the guide member 180 is provided and fixed in the casing 110 . The guide member 180 may form a through-out guide channel (not shown), and may have a width corresponding to the width of the stopper unit 1712 . Additionally, the guide channel is aligned with the first air discharge channel (A) formed by the receptacle of the inner tube driving member 150, so that the stopper portion 1712 controls the direction in which the guide channel extends under the driving of the control unit 1711. can move along, thereby locking the inner tube drive member 150 .

Preferably, the stopper unit 1712 may be coupled to the guide channel by a threaded connection. In other words, when the control unit 1711 rotates, the stopper unit 1712 will screw into the guide channel. As a result, the stopper portion 1712 can be controlled to be locked to the inner tube driving member 150 and fixed to the casing 110 .

Preferably, the locking member 171 may further include a flow control member 1713 disposed inside the second air exhaust channel B and configured to control the flow direction of the air exhaust medium. Preferably, the flow control member 1713 may include a one-way check valve or a controllable lock valve.

7 is a schematic diagram illustrating a one-way check valve according to a first embodiment of the present invention, and FIG. 8 is a schematic diagram illustrating another one-way check valve according to the first embodiment of the present invention. The one-way check valve of FIG. 7 has an I-shaped check orifice 1714 , and the one-way check valve of FIG. 8 has a Y-shaped check orifice 1715 . Of course, the present invention is not limited to the one-way check valve of FIGS. 7 and 8, and other valves capable of one-way check may be suitably used. According to this embodiment, a control locking valve can also be used alternatively. The control lock valve may have a check orifice that can be opened or closed by a user to control the flow direction of the air exhaust medium.

In this embodiment, the external air exhaust medium may flow through at least the second air exhaust channel B, the first air exhaust channel A, and the first space sequentially to the second space and the third space. Preferably, a portion of the air exhaust medium passes through the second air exhaust channel (B), the first air exhaust channel (A), the first space, and the air exhaust opening (131) sequentially to the second space, then can flow into the third space, and the remainder of the air exhaust medium flows directly into the third space by sequentially passing through the second air exhaust channel (B), the first air exhaust channel (A), and the first space can go in

In this embodiment, the air exhaust opening 131 is preferably rectangular as shown in FIG. 5 . As shown in FIG. 6 , it is more preferable that a plurality of, for example, three air outlet openings 131 are formed. Preferably, the plurality of air discharge openings 131 may be evenly distributed along the circumference of the intermediate pipe 130 . Fig. 5 is a schematic diagram showing the intermediate tube according to the first embodiment of the present invention, and Fig. 6 is a cross-sectional view showing the intermediate tube of Fig. 5 cut along the line H-H.

In addition, the rear end of the inner tube 120 protrudes from the intermediate tube 130 to form a third space together with the outer tube 140 , and the front end of the intermediate tube 130 extends from the outer tube 140 to form the inner tube. It should be understood that connected to the drive member. Moreover, when the outer tube driving member 160 is driven to move to the rear end of the casing 110 , the intermediate tube 130 must be long enough so that a part of the intermediate tube 130 is still surrounded by the outer tube 140 . do. In addition, when the intermediate tube 130 forms the air exhaust opening 131 , it may be preferable that the air exhaust opening 131 is also surrounded by the outer tube 140 . In this embodiment, the air discharge opening 131 may be preferably formed at the rear end of the intermediate pipe (130).

2 , the inner tube driving member 150 is disposed at the front end of the casing 110 , and may include a third lumen and a fourth lumen. The third lumen extends axially through the inner tube drive member 150 . The fourth lumen constitutes the first air exhaust channel A and communicates with the first space. Preferably, the central axis of the third lumen may be perpendicular to the central axis of the fourth lumen.

In this embodiment, the front end of the inner tube 120 is inserted into the third lumen and secured to, sealed (eg, welded, bonded, riveted, or otherwise secured to the front end of the inner tube drive member 150 ); sealed). The front end of the third lumen may coincide with the front end of the inner tube 120 . Accordingly, the intermediate tube 130 may be inserted into the third lumen with the front end coincident with the front end of the third lumen adjacent to the fourth lumen. Thereby, when the air discharge medium exits the first air discharge channel (A), it will directly enter the first space between the inner tube (120) and the intermediate tube (130).

Optionally, the intermediate tube 130 may be fixed and sealed to the inner tube driving member 150 by welding, riveting, bonding, sealing ring, or the like at the front end.

In a preferred embodiment, the intermediate tube 130 extends from the inner tube driving member 150 toward the rear end and passes through the outer tube driving member 160 so that the air exhaust medium does not leak through the second space, and passes through the outer tube driving member. may be sealingly connected to 160 . In the case of the intermediate tube 130 forming the air exhaust opening 131 , the intermediate tube 130 may be sealedly connected to the outer tube driving member 160 at the front end of the air exhaust opening 131 .

In addition, the axial extension of the inner tube driving member 150 protrudes from the casing 110 , so that the user can manipulate the inner tube 120 to move forward or backward in the axial direction. In addition, the inner tube 120 may be connected to the front end of the external device by means of a luer taper connection so that the air exhaust medium flows into the inner tube 120 to discharge air from the system. Optionally, the external device may have an air discharge inlet pipe connected to the front end of the inner pipe 120 . In order to prevent backflow, another flow control member (not shown) may be disposed between the air discharge inlet pipe and the inner pipe 120 so as to ensure a unidirectional flow of the air discharge medium. The flow control member may be implemented as, for example, a one-way check valve or a control lock valve.

2 and 3 , the outer tube driving member 160 is disposed toward the rear end from the inner tube driving member 150 within the casing 110 and has a fifth lumen extending axially therethrough. can do. To enable loading and disposition of the artificial heart valve, the outer tube driving member 160 may drive the outer tube to move the outer tube in the axial direction along the casing 110 . The outer tube 140 may be inserted into the fifth lumen at the front end and sealed and fixed to the outer tube driving member 160 . Optionally, the outer tube 140 may be sealed and fixed to the outer tube driving member 160 by welding, riveting, bonding, a sealing ring, or the like. Accordingly, the intermediate tube 130 may extend from the inner tube driving member 150 through the fifth lumen so that the rear end of the intermediate tube 130 is always surrounded by the outer tube 140 . In addition, in the case of the intermediate pipe 130 forming the air exhaust opening 131 , it may be preferable that the air exhaust opening 131 is also always surrounded by the outer pipe 140 .

In a preferred embodiment, in the case of the front end of the intermediate tube 130 sealingly fixed to the inner tube driving member 150 , the rear end of the intermediate tube 130 may be fixed to the inner tube 120 but not sealed. For example, the rear end of the intermediate tube 130 is fixed to the inner tube 120 with respect to the right side of the air exhaust opening 131 (ie, one side farther from the front end of the intermediate tube 130), but may not be sealed. have. As a part of the first space between the inner tube 120 and the intermediate tube 130 is located on the right side of the air exhaust opening 131 , the air exhaust medium enters through the air exhaust opening 131 and the second space. Not only that, it is possible to directly enter the third space between the inner tube 120 and the outer tube 140 through a part of the first space. With this arrangement, not only can the concentricity of the intermediate tube 130 and the inner tube 120 be maintained, but it is also possible to prevent the intermediate tube 130 from acting as a cantilever beam to induce non-uniform stress. This also increases the flow rate of the air discharge medium by allowing the air discharge medium to flow from the first space between the intermediate tube 130 and the inner tube 120 to the third space between the inner tube 120 and the outer tube 140 . can do it Optionally, the intermediate tube 130 is fixed to the inner tube 120 by riveting, welding, bonding, or the like.

The present invention is not limited to the specific structure or configuration of the rear end of the inner tube and the outer tube, which protrudes from the casing, and a person with ordinary knowledge in the related field may select an appropriate structure according to the type of implant, target location, etc. can

In this embodiment, the rear end of the inner tube 120 is disposed at the rear end of the anchor 121, the inner tube rear portion (distal section) 122 connected to the anchor 121, and the inner tube rear portion 122 It may include a conical end 123 . The anchor 121 may form a recess into which the implant may be loaded. A sheath 141 for restraining the implant in a crimped configuration may be disposed at the rear end of the outer tube 140 . The sheath 141 may have a length corresponding to the length of the inner tube rear portion 122 .

The operation process of the implant delivery device 100 according to this embodiment will be described below in relation to the detailed structure described above.

Air exhaust: The trailing ends of the outer tube 140 and the inner tube 120 are immersed in an air exhaust medium (eg water, such that the trailing ends are placed in, for example, an aqueous environment). . Then, the air exhaust medium is introduced into the second space and the third space by the air exhaust lock assembly 170 to exhaust the air between the outer tube 140 and the inner tube 120 from the system. The air exhaust medium is also introduced into the lumen through the luer taper to exhaust the air in the lumen of the inner tube 120 .

Implant loading: the locking lugs of the implant are first hooked to the anchor 121 of the inner tube 120 , and then the outer tube 140 is moved toward the rear end of the implant delivery device 100 , so that the sheath 141 ) accommodates the implant on the inner tube rear portion 122 and the inner tube rear portion 122 . As a result, the implant is crimped and constrained between the outer tube 140 and the inner tube 120 .

Delivery and placement of the implant: After loading the implant, the implant is delivered to the patient's body with the inner tube 120 fixed to the outer tube 140 . After advancing the implant to the target position, the outer tube 140 is manipulated to move toward the front end of the implant delivery device 100 so that the sheath 141 slides out of the implant. The implant released from the restraining stress of the sheath 141 will self-expand and remain stable in the lesion position.

Retrieval of the delivery device: After the implant is placed in the lesion location, the inner tube drive member 150 is released from the air release lock assembly 170 so that the inner tube 120 is directed toward the front end of the implant delivery device 100 . act to move. As a result, the front end of the conical end 123 is adjacent to the rear end of the outer tube 140 to close the rear ends of the inner tube 120 and the outer tube 140 , and then the delivery device is withdrawn from the patient's body.

In the above-described embodiments, the casing 110 is implemented as a handle, for example, and may serve as a base on which various components of the implant delivery device 100 are mounted or attached. For example, the inner tube drive member 150 and the outer tube drive member 160 may be disposed within the casing 110 to be axially movable along and relative to the casing 110 . The inner tube 120 may be connected to the inner tube driving member 150 at the front end and the rear end may protrude from the rear end of the casing 110 . The air exhaust lock assembly 170 may be partially received within the casing 110 to move relative to the casing 110 . The present invention is not limited to a specific material, shape, or size of the casing 110 , and is suitable for a user to hold and manipulate and includes a portion of the inner tube 120 , a portion of the intermediate tube 130 , a portion of the outer tube 140 and other configurations Any existing structure capable of accommodating elements or a structure to be developed in the future can be suitably used as the casing 110 of the implant delivery device 100 of the present invention.

In this embodiment, the implant delivery device 100 may further include a movement control member and a movement guide track disposed on the casing 110 . The movement control member may be movably disposed on the movement guide track and connected to the outer tube driving member 160 . The user may operate the movement control member so that the movement control member moves along the movement guide track so that the outer tube driving member 160 and the outer tube 140 move at the same time.

In the above-described embodiments, the intermediate tube 130 may be formed of a polymer material or a metal material. The metallic material may be a metal such as stainless steel, titanium, or gold, or an alloy such as nickel-titanium or cobalt-nickel. The polymer material may be one or more of polycarbonate, polypropylene, polyamide, polyimide, and acrylonitrile-butadiene-styrene copolymer. Of course, it will be appreciated by those skilled in the relevant art that the intermediate tube 130 may also be formed of any suitable material that may be developed in the future and selected based on the environmental requirements of the implantation process.

In addition, each of the outer tube 140 and the inner tube 120 may be composed of multiple braided layers or may be made of a metal, a polymer material, or other chemical material suitable for medical use. In general, both the outer tube 140 and the inner tube 120 should have a high optical direction stretch resistance value and some degree of bendability in a direction perpendicular to the axial direction.

<Example 2>

9 is a schematic diagram illustrating an implant delivery device according to a second embodiment of the present invention. 10 is a schematic diagram illustrating an air exhaust lock assembly connected to an inner tube drive member in an implant delivery device according to a second embodiment of the present invention; 11 is a partial schematic view showing the air exhaust lock assembly separated from the inner tube driving member in the implant delivery device according to the second embodiment of the present invention. 9 , the casing 110 , the outer tube 140 , and the outer tube driving member 160 are not shown. This embodiment is essentially different from the first embodiment in the air exhaust lock assembly, and similar structural details may refer to the first embodiment.

In the implant delivery device 200 of the present embodiment, the air release lock assembly 210 includes a lock member 211 and a fluid member 212 . The locking member 211 is removably connected to the inner tube driving member 220 and interconnected with the fluid member 212 .

Unlike the first embodiment, the air exhaust lock assembly 210 includes a lock member 211 and a fluid member 212 . The fluid member 212 may be partially positioned outside the casing 110 and configured to introduce an air exhaust medium. Similarly, the locking member 211 may also be partially positioned outside the casing 11 so that the user can easily manipulate the locking member 211 . Unlike the first embodiment, the locking member 211 has a sixth lumen, wherein the sixth lumen is connected to the first air exhaust channel A when the locking member 211 is connected to the inner tube driving member 220 . communicate The fluid member 212 may have a seventh lumen extending therethrough. The sixth lumen and the seventh lumen may communicate with each other to form a second air exhaust channel (B).

Additionally, similarly to the first embodiment, the locking member 211 may include a control unit 2111 and a stopper unit 2112 . The stopper unit 2112 may be configured to be coupled to the inner tube driving member 220 , and the control unit 2111 may be configured to drive and move the stopper unit 2112 . Likewise, one end of the control unit 2111 may protrude from the casing 110 to facilitate the user's operation. However, unlike the first embodiment, the sixth lumen is provided only by the stopper portion 2112 . When the stopper part 2112 is coupled to the inner tube driving member 220 , the sixth lumen communicates with the first air discharge channel A.

In addition, the stopper portion 2112 may further include an eighth lumen extending axially therethrough, the eighth lumen having the locking member 211 on the inner tube drive member 220 and a sleeve (sleeve). let it do The eighth lumen may communicate with the sixth lumen, and preferably, the central axis of the eighth lumen may be perpendicular to the central axis of the sixth lumen.

In a preferred embodiment, the stopper part 2112 may include a stopper body 2113 and an elastic structure 2114 . The stopper body 2113 is configured to engage the inner tube driving member 220 . The stopper body 2113 has a sixth lumen. The elastic structure 2114 is connected to the stopper body 2113 . The stopper part 2112 may be maintained in a state of being connected to the inner tube driving member 220 through the elastic structure 2114 . When the elastic structure 2114 is stressed, the stopper part 220 is separated from the inner tube driving member 220 through the elastic structure 2114 .

Also similar to the first embodiment, the inner tube driving member 220 may define a third lumen, a fourth lumen and a receptacle. A third lumen extends axially through the inner tube drive member 220 . The fourth lumen is in communication with the third lumen. In the axial direction, the stopper body 2113 may have a width corresponding to the width of the receptacle. The fourth lumen may serve as the first air exhaust channel A and may be formed by a receptacle (eg, the receptacle, wherein the vertical part constitutes the first air exhaust channel A and the horizontal part constitutes a stopper body) (2113) may have a T-shaped structure coupled to). When the stopper body 2113 is coupled to the inner tube driving member 220, the first air exhaust channel (A) communicates with the second air exhaust channel (B), so that the external air exhaust medium is connected to the second air exhaust channel (B). ), through the first air outlet channel A and the first space to the second space (between the middle tube 130 and the outer tube 140), and then to the second space (between the middle tube 130 and the outer tube 140), and then (the inner tube 120 and the outer tube 140) )) will flow into the third space. As shown in FIG. 10 , unlike the embodiment shown in FIG. 2 , the air discharge opening 131 of the intermediate tube 130 may not be surrounded by the outer tube 140 . In this case, a portion of the air discharge medium passes through the second air discharge channel (B), the first air discharge channel (A), the first space, and the air discharge opening 131 sequentially to pass through the intermediate pipe 130 and the outside It will flow into the gap between the tube drive members 160 . Since both the middle tube 130 and the outer tube 140 are sealingly connected to the outer tube driving member 160 , a limited space is formed, and the inner tube 130 and the outer tube driving member 160 flow into the gap between them. The air exhaust medium will continue to flow into the second space between the intermediate tube 130 and the outer tube 140 and then into the third space. On the other hand, the remaining air exhaust medium will flow directly into the third space through the second air exhaust channel B, the first air exhaust channel A and the first space.

In this embodiment, the elastic structure 2114 may include elastic fingers formed of an elastic material. One end of the elastic finger is connected to the stopper body 2113 , and the other end of the elastic finger may be in contact with the support member 230 disposed in the casing 110 and fixed to the casing 110 . Alternatively, the elastic structure 2114 may be implemented as a spring having one end connected to the stopper body 2113 and the other end contacting the support member 230 . The spring may provide a biasing force that can be coupled to the stopper body 2113 and the inner tube driving member 220 . In summary, the stopper body 2113 is coupled to the inner tube driving member 220 by the elastic structure 2114 . When the biasing force provided by the elastic structure 2114 is relieved by the control unit 2111 , the stopper unit 2112 is driven and lowered, so that the stopper body 2113 will be separated from the receptacle of the inner tube driving member 220 . . As a result, the inner tube driving member 220 will move axially along the casing 110 .

In this embodiment, the fluid member 212 may include a fluid member body 2121 and a connection pipe 2122 . The fluid member body 2121 defines a lumen extending axially therethrough. The connection pipe 2122 has one end connected to the fluid member body 2121 and the other end connected to the stopper part 2112 . The lumen of the fluid member body 2121 communicates with the inside of the connection tube 2122 , and together with the interior of the connection tube may constitute a seventh lumen. In addition, the seventh lumen and the sixth lumen may together constitute the second air exhaust channel (B). In this embodiment, the fluid member body 2121 is constrained to the casing 110 , and a part thereof may protrude outside the casing 110 to receive the air discharge medium and be connected to an external device.

The fluid member 212 may further include a flow control member 2123 disposed on the fluid member body 2121 to limit and control the flow direction of the air discharge medium. Preferably, the flow control member 2123 may include a one way check valve or a control lock valve. More preferably, the flow control member 2123 may be integral with the fluid member body 2121 .

Although several preferred embodiments of the present invention have been described above, the present invention is not limited to the scope of these embodiments. Those of ordinary skill in the relevant art will appreciate that other approaches for enabling engagement and disengagement between the locking member and the inner tube drive member may be incorporated herein by reference.

In addition, those skilled in the relevant art will understand that the diameter and length of the inner tube and the outer tube according to the present invention correspond to each other, and a decision should be made based on the actual implementation procedure environment.

In the embodiments disclosed above, when it is described that two components are "sealedly connected" to each other, this means that these components are movable with respect to each other and sealed with each other. When two components are described as being "sealed" to each other, this means that these components are sealed to each other and cannot move relative to each other.

Compared with the prior art, the inner tube of the implant delivery device of the present invention may be connected to or movable relative to the casing by engagement or disengagement between the inner tube drive member and the air exhaust lock assembly, according to actual needs. . Thereby, when the delivery device is withdrawn after implant delivery, the outer tube remains stationary, and the inner tube driving member is air driven so that the inner tube moves within the casing and approaches and abuts the outer tube to close the outer tube. Released from the ejection lock assembly, the delivery device is then withdrawn from the patient's body. Specifically, the sheath needs to be relatively rigid because the sheath disposed at the rear end of the outer tube must constrain the implant to the crimping configuration. For this reason, in the prior art, if the inner tube and the outer tube are driven to be adjacent to each other for closure after implant placement, secondary damage is caused to the patient's body by the sheath. Conversely, according to the present invention, the inner tube is made of a material having a smaller size, greater bendability and flexibility, and the rear end is adjacent to the rear end of the outer tube through displacement to close the outer tube. Due to this, it is possible to lower the risk of causing secondary damage to the patient's body during recovery. Additionally, in the implant delivery device of the present invention, the second air exhaust channel disposed in the air exhaust lock assembly is intermediate through the first air exhaust channel in the inner tube drive member and the first space between the intermediate tube and the inner tube. It communicates with the second space between the tube and the outer tube and the third space between the outer tube and the inner tube, so that air can be discharged from between the inner tube and the outer tube. This design uses the air exhaust lock assembly instead of the air exhaust hose, thereby solving the problem of the air exhaust path being deformed or blocked by the use of the air exhaust hose, making it impossible to exhaust the air from the system. In addition, this air exhaust and lock integrated design integrates the air exhaust and lock function, thereby reducing the number of components required and simplifying the operation process. As a result, the delivery device can be used more conveniently with increased performance rigidity.

The above description is only for some preferred embodiments of the present invention, and does not limit the scope of the present invention. All changes or modifications made by those skilled in the art based on the above description fall within the scope defined by the appended claims.

100, 200: implant delivery device 110: casing
120: inner tube 121: anchor
122: rear portion of the inner tube 123: conical rear end
130: intermediate pipe 131: air exhaust opening
140: exterior 141: sheath (sheath)
150, 220: inner tube driving member 160: outer tube driving member
170, 210: air exhaust lock assembly 171, 211: lock member
1711, 2111: control unit 1712, 2112: stopper unit
1713, 2123: flow control member 2113: stopper body
2114: elastic structure 212: fluid member (fluidic member)
2121: fluid member body 2122: connector
1714, 1715: check orifice
180: guide member 190: sealing ring
230: support member A: first air exhaust channel
B: second air exhaust channel

Claims (15)

In the implant delivery device,
casing; and
an inner tube drive member, an outer tube drive member, an inner tube, an intermediate tube, an outer tube, and an air exhaust lock assembly, each of which is at least partially received in the casing;
The inner tube, the intermediate tube and the outer tube are sequentially arranged from the inside to the outside, the inner tube and the intermediate tube form a first space between each other, the intermediate tube and the outer tube form a second space between each other, , The inner tube and the outer tube form a third space between each other,
The inner tube driving member has a front end sealed and fixed to the front end of the inner tube, the outer tube driving member is sealingly fixed to the front end of the outer tube, and the intermediate tube has a front end sealed and fixed to the inner tube driving member wherein the intermediate tube extends through the outer tube drive member and is sealingly connected to the outer tube drive member, and the air exhaust lock assembly is removably connected to the inner tube drive member,
The inner tube drive member has a first air exhaust channel, the air exhaust lock assembly has a second air exhaust channel, the second air exhaust channel protrudes from the casing at a first end, the air exhaust When the locking assembly is connected to the inner tube drive member, the second end communicates with the first air exhaust channel and the second space and the third space through the first space, the inner tube drive member allows the air exhaust wherein the inner tube drive member is axially slidable along the casing when the air exhaust lock assembly is disengaged from the inner tube drive member. , an implant delivery device.
The method of claim 1,
wherein the air exhaust lock assembly includes a locking member removably connected to the inner tube drive member, the locking member having a lumen extending through the locking member to define the second air exhaust channel. which is an implant delivery device.
3. The method of claim 2,
The locking member includes a stopper part detachably connectable to the inner tube driving member and a control part for driving the stopper part to move, wherein the control part has a first end located outside the casing and is passed through the control part. wherein the first lumen extends, the stopper portion having a second lumen extending through the stopper portion, the first lumen and the second lumen communicating with each other to form the second air exhaust channel , an implant delivery device.
4. The method of claim 3,
A guide member provided in the casing is further provided, wherein the guide member has a guide channel extending therethrough, and the stopper part is movable with respect to the inner tube driving member along an extension direction of the guide channel. which is an implant delivery device.
The method of claim 1,
The inner tube drive member has a third lumen and a fourth lumen, the third lumen extending axially through the inner tube drive member, the third lumen having a rear end coincident with the front end of the intermediate tube and having a front end coincident with the front end of the inner tube, wherein the fourth lumen constitutes the first air exhaust channel and is in communication with the first space.
The method of claim 1,
The outer tube drive member has a fifth lumen extending axially therethrough, wherein the front end of the outer tube is located in the fifth lumen, and the intermediate tube extends from the inner tube drive member through the fifth lumen. An implant delivery device, characterized in that it is extended.
The method of claim 1,
The air exhaust lock assembly includes a lock member removably connected to the inner tube driving member and a fluid member fixedly connected to the lock member, wherein the lock member has a portion located outside the casing and the first air a sixth lumen in communication with the leak channel, the fluid member having a seventh lumen extending therethrough, the sixth lumen and the seventh lumen communicating with each other to form the second air leak channel Characterized in that, the implant delivery device.
8. The method of claim 7,
The locking member includes a stopper part detachably connectable to the inner tube driving member and a control part for driving the stopper part to move, the control part having a first end located outside the casing, the stopper part and comprising the sixth lumen.
9. The method of claim 8,
The stopper portion includes a stopper body detachably connected to the inner tube driving member and an elastic structure connected to the stopper body, wherein the stopper portion is connected to the inner tube driving member through the elastic structure, and the elastic structure is When subjected to stress, the implant delivery device, characterized in that the stopper portion is separated from the inner tube driving member.
The method of claim 1,
wherein the air outlet lock assembly has a flow control member for controlling the flow direction of the air exhaust medium, wherein the flow control member is disposed in the second air outlet channel.
11. The method of claim 10,
wherein the flow control member has a one way check valve or a control lock valve.
The method of claim 1,
The intermediate pipe has an air exhaust opening at a rear end through which the first space communicates with the second space, wherein when the air exhaust lock assembly is connected to the inner tube driving member, the second end of the second air exhaust channel is brought into communication with the second volume and the third volume through the first air outlet channel, the first volume, and the air outlet opening.
13. The method of claim 12,
wherein the intermediate tube has a plurality of air outlet openings uniformly distributed around the circumference of the intermediate tube.
The method of claim 1,
The rear end of the intermediate tube is fixed to the inner tube, but is not sealed.
The method of claim 1,
Implantation, further comprising a movement control member and a movement guide track, wherein the movement guide track is disposed on the casing, and the movement control member is disposed on the movement guide track and is connected to the outer tube drive member. water delivery device.

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